Interbody fusion device

ABSTRACT

Devices for fixing interbody fusion devices to bone by helically or corkscrew-shaped elements are provided. Methods for surgically implanting an interbody fusion device using helically-shaped fixation wire are provided.

RELATED APPLICATION INFORMATION

This application is a continuation of U.S. application Ser. No.15/665,774, filed Aug. 1, 2017, which is a divisional of U.S.application Ser. No. 13/768,922, filed Feb. 15, 2013, which claimspriority under 35 U.S.C. § 119(e) to U.S. Provisional Patent ApplicationNo. 61/600,435, filed Feb. 17, 2012, the disclosure of each isincorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates generally to systems and methods for performingspinal fixation and, in particular, to interbody spacer devices.

Description of the Related Art

Advancing age, as well as injury, can lead to degenerative changes inthe bones, discs, joints and ligaments of the spine, producing pain andinstability. Under certain circumstances, alleviation of the problemscan be provided by performing spinal fusion. Spinal fusion is a surgicaltechnique where two or more vertebrae of the spinal column are fusedtogether to eliminate the motion between the fused vertebrae. Spinalfusion is used to treat conditions where the spine exhibits instability.Spine instability may result from causes such as fracture, scoliosis andspondylolisthesis, where one or more vertebrae move in a forwarddirection relative to the other vertebrae. Spinal fusion with discectomyis also performed for herniations of the discs. This surgery involvesremoval of the affected disc and fusion of the adjacent vertebrae.Traditionally, bone grafts have been used to fuse the vertebrae, butvarious types of vertebral implants have also been used.

The use of bone plate and bone screw fixation systems for treatinginjuries to bones is well established. In most instances, a bone plateis positioned over and surrounding the bone injury area and secured tothe bone. The bone plate is secured to the bone by bone screws or othersimilar fasteners inserted through holes in the bone plate and into thebone itself. The screws are tightened so that the bone plate holds thebone to be treated in place in order to insure proper healing. Earlyfixation devices tended to be applicable only to long bone injuries withonly limited uses for lower lumbar spinal injuries and disorders. Theuse of plate/screw fixation systems later expanded, however, to includemore uses for spinal injuries, including fusion of vertebrae includingfixation devices for treating cervical vertebrae injuries.Notwithstanding the foregoing, there remains a need for improved methodsand devices for treating spinal instability.

SUMMARY OF THE INVENTIONS

An implantable device for supporting bony structures comprises a spaceror plate element including at least one opening extending at leastpartially through the spacer or plate element. A helically-shapedelement is configured to extend through the opening to secure the spaceror plate element to a bone.

In one arrangement, the opening in the space element includes a groovewith a helical shape of corresponding diameter and pitch as thehelically-shaped element In another arrangement, an interbody spacersystem for the spine comprises a helically-shaped wire and an implantbody having a hole through which the wire passes that is smaller indiameter than the outer diameter of the wire.

In certain arrangements, the helical shape of both the wire and a grooveor indentation in the spacer can be correspondingly timed (e.g., havinga rotational position about the axis of the helix) such that as thehelically-shaped wire passes through the spacer, the sharp tip is thefirst portion of the wire to come in contact with the bony structures.In certain arrangements, the helically shaped element and groove aretimed with respect to having a common rotational position about the axisof a helix

The helically-shaped element may include a sharp tip capable of piercingthe bone on one end and a feature that engages a driving instrument onthe opposite end. In some arrangements, the sharp tip comes into contactwith the bone from a generally perpendicular direction.

In some arrangements, the device may comprise a design feature thatprevents the helical-shaped element from turning once it has reached itsfinal desired implanted position.

In some arrangements, the device is configured such that thehelically-shaped element extends through the opening to secure thespacer element to a superior vertebral body. The spacer element may haveat least a second opening configured such that a second helically-shapedelement extends through the second opening to secure the spacer elementto an inferior vertebral body.

In some arrangements, the opening in the spacer implant furthercomprises a hole insert. The hole insert may have a groove with acorresponding diameter and pitch to the helically-shaped element.

Another arrangement, a method for treating a spine comprises insertingan interbody spacer between two vertebral bodies and inserting acorkscrew-shaped fixation device through an opening in the interbodyspacer to secure the interbody spacer to a vertebral body. Some methodsmay further comprise engaging a proximal end of the corkscrew-shapedfixation device to a proximal feature of the opening in the interbodyspacer. Other methods may further comprise inserting a secondcorkscrew-shaped fixation device through a second opening in theinterbody spacer to secure the interbody spacer to a second, adjacentvertebral body.

In some arrangements, an interbody spacer system for the spine comprisesa helically-shaped wire, a spacer, and a plate having at least one holethrough which the wire passes to secure the plate to a vertebral bodyadjacent to the spacer. The hole through which the wire passes may insome instances be of corresponding diameter and pitch as thehelically-shaped wire. In other instances, the hole through which thewire passes is smaller in diameter than the outer diameter of thehelically shaped wire. The system may further comprise a hole insert inthe plate hole. In some arrangements, the plate may be attached to theinterbody spacer.

BRIEF DESCRIPTION OF THE DRAWINGS

The structure and method of using the invention will be betterunderstood with the following detailed description of embodiments of theinvention, along with the accompanying illustrations, in which:

FIG. 1 is a view portion of the vertebral column with an interbodydevice positioned therein.

FIG. 2A is a front perspective view of a interbody spacer.

FIG. 2B is a view of an exemplary helical fixation device

FIG. 2C is a view of the proximal segment of an exemplary helicalfixation device.

FIG. 2D is a view of the proximal segment of an exemplary helicalfixation device.

FIG. 3 is a front perspective view of a interbody spacer.

FIG. 4 is a front perspective view of a interbody spacer with a helicalfixation device in a first position.

FIG. 5 is a front perspective view of a interbody spacer with a helicalfixation device in a second position.

FIG. 6 is a front perspective view of a interbody spacer with a helicalfixation device in a third position.

FIG. 7 is a front perspective view of a interbody spacer positionedbetween vertebral bodies with a helical fixation device in a firstposition.

FIG. 8 is a front perspective view of a interbody spacer positionedbetween vertebral bodies with a helical fixation device in a secondposition

FIG. 9 is a side perspective view of a interbody spacer positionedbetween vertebral bodies with a helical fixation device in a firstposition.

FIG. 10 is a front perspective view of a interbody spacer positionedbetween vertebral bodies with a helical fixation device in a secondposition.

FIG. 11 is a front perspective view of a interbody spacer positionedbetween vertebral bodies with a helical fixation device in a thirdposition.

FIG. 12A is a view of a helical fixation device with a protrusionproximally

FIG. 12B is a front perspective view of an interbody spacer with agroove for receiving helical spacer protrusion.

FIG. 12C is a view of a helical fixation device and cap for helicalfixation device.

FIG. 13 is a view of a portion of a spacer system with hole insert forhelical fixation device.

FIG. 14 is a view of a flanged fusion device for use with one or morehelical fixation devices.

FIG. 15 is a view of a plate for use with one or more helical fixationdevices.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The vertebral column 2 comprises a series of alternating vertebrae 4 andfibrous discs 6 that provide axial support and movement to the upperportions of the body. The vertebral column 2 typically comprisesthirty-three vertebrae 4, with seven cervical (C1-C7), twelve thoracic(T1-T12), five lumbar (L1-15), five fused sacral (S1-S5) and four fusedcoccygeal vertebrae. FIG. 1 depicts a portion of the cervical spine withan embodiment of a interbody spacer system 20 positioned therein. Thetypical cervical vertebrae differ from the other vertebrae withrelatively larger spinal canal, oval shaped vertebral bodies, bifidspinous processes and foramina in their transverse processes. Theseforamina transversaria contain the vertebral artery and vein. The firstand second cervical vertebrae also further differentiated from the othervertebrae. The first cervical vertebra lacks a vertebral body andinstead contains an anterior tubercle. Its superior articular facetsarticulate with the occipital condyles of the skull and are oriented ina roughly parasagittal plane. The cranium is able to slide forward andbackwards on this vertebra. The second cervical vertebra contains anodontoid process, or dens, which projects superiorly from its body. Itarticulates with the anterior tubercle of the atlas, forming a pivotjoint. Side to side movements of the head occur at this joint. Theseventh cervical vertebra is sometimes considered atypical since itlacks a bifid spinous process.

In the figures and description herein, interbody spacer system 20 isshown positioned between the cervical vertebrae. However, it should beappreciated that in other arrangements the system 20 can be utilized inother portions of the spine.

The interbody system 20 comprises an interbody spacer or body 30 shownin FIGS. 2 and 3. The interbody spacer 30 can comprise any structureconfigured to maintain a separation and resist compression between twoadjacent vertebral bodies. The spacer can have any of a variety ofoverall shapes, including but not limited to a rectangular box, atrapezoidal box, H-shaped, O-shaped, V-shaped, with or without one ormore lumens within the spacing structure. As shown in FIGS. 2 and 3, thespacer 30 comprises a body 114 that can have an anterior surface 116, asuperior surface 118 and an inferior surface 120, and side surfaces 122,124, and a posterior surface 126. Each surface 116, 118, 120, 122, 124,126 need not be flat, and can be curved or undulating or any combinationthereof. The upper and lower surfaces 118, 120 can be configured forfacing the superior and inferior vertebral bodies adjacent to animplantation site. The relative configuration of the upper surface 118and lower surface 120 can vary, depending upon the relative positiondesired between the two adjacent vertebrae, the anatomical shape of thevertebrae, ease of insertion of the implant and other factors. Forexample, if a neutral vertical alignment is desired between twovertebrae, the upper and lower surfaces 118, 120 can have generallyparallel planar orientations. If a non-neutral alignment is desired, forinstance to maintain a natural spinal curvature in the cervical region,the upper and lower surfaces 118, 120 can have a wedge-like relationshipto allow fixation of the vertebrae in the desired non-neutral position.A non-neutral alignment with respect to the anterior-posterior directioncan also be used to compensate for excessive lordosis or kyphosis inother portions of the vertebral column. The height of the body 114 atany section between the upper and lower surfaces 118, 120 can be furtherconfigured to accommodate degenerative changes or anatomical anomaliesto provide fixation in the desired relative position. Likewise, the sidesurfaces 122, 124 of the spacing structure 114 can be generally parallelor skewed. In some embodiments, the side surfaces 122, 124 of theimplant 30 taper with increasing distance from the anterior side 116 ofthe implant 100. A tapered spacing structure can facilitate insertion ofthe implant 30 into the intervertebral space. In other embodiments, theone or more side surfaces can flare distally or have both tapering andflaring portions.

FIGS. 2 and 3 illustrate an embodiment comprising a spacer 30 withwindows or holes 146 between the outer surfaces. These windows or holescan allow bony growth into the windows or holes. The space 146 withinand/or between the posterior members can also be filled with graftmaterials (not shown). The graft material can be an autograft,allograft, xenograft or synthetic material. Synthetic graft material canbe ceramic-based, silicon-based or calcium-based. The graft material canalso include osteoinductive factors to promote bone ingrowth. Oneskilled in the art will appreciate that there are many varieties ofsynthetic graft materials and constituents that can be used between orabout the hyoid bone segments.

One or more surfaces of the implant can also have surface projections,indentations, or holes or pores that can further alter thecharacteristics of the implant. Referring to FIGS. 2 and 3, in someembodiments, angled projections, barbs, teeth 154 or ramped surfaces canincline outwardly from one or more spacer surfaces and can be providedon one or more surfaces that allow insertion of the spacing structure inone direction but resist movement in the opposite direction. These teeth154 can be advantageous in reducing the migration of the device out ofthe intervertebral space. Improved fixation of the spacer 30 canmaintain device position during initial placement between vertebralbodies, and can also reduce the forces acting upon the screws or otherretaining structures (described below), thereby reducing the risk ofbackout. The teeth 154 are preferably provided on the superior and/orinferior surfaces 118, 120 of the spacer 30, but other surfaces can alsohave teeth or other tissue engagement structures.

In some embodiments, the tissue engagement structures can be combinedwith indentations, holes or pores for allowing bony ingrowth or fillingwith bony matrix or graft materials as previously described. These holescan be utilized with other surface features to further enhance insertionand stabilization of the implant.

In some embodiments, the spacer can have a height of about 4 mm to about50 mm, or preferably about 4 mm to about 12 mm. In some embodiments, thespacer can have a height of about 6 mm to about 9 mm. In someembodiments, the spacer can have a length as measured from the bonefacing surface of the fixation plate to the most posterior end of thespacer of about 5 mm to about 25 mm. In some embodiments, the spacerlength can be about 10 mm to about 15 mm. The width of the spacer can begenerally about 5 mm to about 25 mm, and in some situations, about 10 mmto about 15 mm. One skilled in the art can dimension the spacer basedupon the implantation location and specific vertebral morphology,neurological anatomy and disease state.

The spinal fusion implant can include, be made of, treated, coated,filled, used in combination with, or contain artificial or naturallyoccurring materials suitable for implantation in the human spine. Thesematerials can include any source of osteogenesis, bone growth-promotingmaterials, bone derived substances, bone morphogenetic proteins,hydroxyapatite, genes coding for the production of bone, and boneincluding, but not limited to, cortical bone. The implant can also beformed of material such as metal including, but not limited to, titaniumand its alloys, surgical grade plastics, plastic composites, ceramics,or other materials suitable for use as a spinal fusion implant. In someembodiments, the device can comprise a radiolucent material, aradio-opaque material, or a combination thereof. A device that ispartially or completely radiolucent can be advantageous when evaluatingthe effect of the implant post-implantation. Many existing spinalfixation plates and/or spacers obscure visualization of the vertebrae,which can complicate post-operative treatment, diagnosis and prognosisof the patient's condition. The implant can include at least in partmaterials that are bioabsorbable in the body. The implant of thedescribed embodiments can be formed of a porous material or can beformed of a material that intrinsically participates in the growth ofbone from one of adjacent vertebral bodies to the other of adjacentvertebral bodies. The implant can be treated with, coated with, or usedin combination with substances to inhibit scar tissue formation. Theimplant of the described embodiments can be modified, or used incombination with materials to provide antibacterial properties, such as,but not limited to, electroplating or plasma spraying with silver ionsor other substance. The implant can optionally comprise an electricalsource to provide ionophoresis of the silver ions into the surroundingtissue to prevent infection. The antibacterial properties can includebactericidal and/or bacteriostatic characteristics. Similarly,anti-fungal characteristics can also be provided. Any of these materialsas appropriate can be used at any time after the implant(s) areinserted.

To secure the spacer 30 between vertebral bodies, the system 20 caninclude a fixation device 50 shown in FIGS. 4-11. In the illustratedembodiment, the fixation device 50 can comprise a helical and/orcorkscrew shaped body 52 or wire with a proximal end 54 and a distal end56. See FIG. 5. The distal end 56 can be formed into a sharp tip thatcan be configured to penetrate bone (e.g., the endplates of thevertebral body). The proximal end 54 can be configured to engage adriving instrument. For example, as in FIGS. 2C-D, the proximal end mayhave a portion with hexagonal shape, protruding slot, or threading toengage corresponding hex-headed or threaded driver. Alternatively, theproximal end of the fixation device may have central bore with femalethreads, internal hex, or any other method of removably coupling to adriver. In some embodiments, the fixation device 50 can be formed of ametal such as, for example, titanium or titanium alloy. The device 50can be formed in a variety of ways, such as, for example by bending astraight wire or rod into a helical or corkscrew arrangement. In otherembodiments, the device 50 can be machined or otherwise formed into theillustrated arrangement. In some embodiments, the device 50 may be madeof PEEK or other radiolucent material.

Referring to FIGS. 2-11, the spacer 30 can have one or more spaces orholes 112 extending from the anterior surface 116 of the spacer 30. Theholes 112 are configured to accept the fixation device 50 describedand/or other attachment elements for anchoring the body 30 to thevertebral bone. In the illustrated embodiment, one screw hole 112 isslanted or orientated such that the opening is directed towards thesuperior vertebral body and the other hole 112 is slanted or orientatedsuch that the opening is directed towards the inferior superior body.

In the illustrated arrangement, the hole 112 includes a groove 200. Thegroove 200 can be configured to have the same or similar helical shape(e.g., corresponding diameter and pitch) as the fixation device 50. Inthis manner, in one arrangement, the helical shape of both the fixationdevice 50 and the groove 200 can being correspondingly timed (e.g.,having a rotational position about the axis of the helix) such that asthe helically-shaped device 50 passes through the body 30, the sharp tipis the first portion of the fixation device 50 to come in contact withthe bony structures. See e.g., FIG. 10. The tip 56 may come into contactwith the bony structure generally perpendicular to the bony surface.This arrangement advantageously inhibits the fixation device 50 frombeing deflected away from the vertebral body as it is inserted into thebone. In other embodiments, the body 30 can be formed without thegroove. The spacer 30 and/or the fixation device 50 can include a designfeature that prevents the fixation device 50 from turning once it hasreached its final desired implanted position. For example, in onearrangement, as shown in FIGS. 12A-B, the proximal end 54 of thefixation device 50 and the body 30 can have interlocking shapes 254, 256that interlock to limit rotation of the fixation device once it hasreached its fully inserted position. For example, a protrusion from thefixation device may interlock with a corresponding groove or slot in thebody at the entrance to the hole. Alternatively, in another arrangement,shown in FIG. 12C, a supplemental component 72 such as a cap may becoupled a complementary surface of the proximal end of the helicalfixation device 66 or body 30 to cover or limit rotation of the fixationdevice (e.g. by providing interference to rotation). This may couple tothe fixation device or body through threads, friction fit, or any othercoupling mechanism. The cap may have a central stem with male threadingto engage central bore in the proximal end of the fixation device. Theremay be corresponding groove in the body for receiving the supplementalcomponent or the supplemental component may block further insertion.

In other arrangements, the hole 112 in the spacer may have a diameterwhich is smaller than the outer diameter of the helix. In somearrangements, the hole has a groove 200 which is smaller than the outerdiameter of the helix and has a correspondingly larger pitch than thatof the helix. In other arrangements, there is no groove.

In some arrangements, as shown in FIG. 13, the hole 212 in the system300 may have a hole insert 256 through some or all of the opening in theplate or spacer. The hole insert 256 provides an intermediate layer ofmaterial between the helical fixation device and the inner surface ofthe flange hole 200. The hole insert 256 may comprise a generallypolymer, metallic, or ceramic member comprising an outer flange holecontacting surface and an inner fixation device contacting surface,where the outer flange hole contacting surface is shaped to conform toat least a portion about the inner surface of the flange hole 112. Thehole insert may have a helical groove 200 on the inner fixation devicecontacting surface corresponding to the pitch and diameter of thehelical element. In one embodiment of the invention, the flange holeinsert 256 is capable of absorbing wear forces transmitted between thesystem 300 and the helical fixation element. The hole insert 256 maycomprise a material complementary to the material used in the helicalelement, to reduce wear. Absorption of the forces between these twocomponents of the implant may reduce the risk of implant failure and/orloosening that occurs at the interface between the two components.

In one preferred embodiment, the flanged interbody device comprises apolyaryl polymer, including but not limited to PEK, PEEK, PEKK, PEKEKKor a blend thereof, and the insert comprises a titanium or titaniumalloy. Other combinations may also be used as is known by those withskill in the art.

While a flanged interbody fusion device 300 is shown in FIG. 13, holeinserts may likewise be used in openings in an interbody spacer 30 suchas those shown in FIGS. 1-11 or in a plate 400 such as that shown inFIG. 15.

The fixation device 50 described has certain advantages over traditionalfixation screws used with interbody spaces. For example, as compared toscrews, a screw hole does not need to be prepared. Accordingly, theprocedure can be faster. In addition, less bone is removed from thevertebral body. The fixation device 50 can also have increased pull outstrength as compared to screws.

It should be appreciated that while the fixation device 50 is shown withan interbody spacer in other embodiments the fixation device can be usedwith other spinal fixation devices, such as, for example, a flangedinterbody devices and various plates (e.g., cervical plates). In oneembodiment of the invention, an interbody vertebral implant 300 isprovided. As shown in FIG. 14, in one embodiment the implant 300comprises a stabilization or fixation plate 302 having an upper portion304 and a lower portion 306, and a bone facing surface 308 and an accesssurface 310. In use, typically the bone facing surface 308 will actuallycontact the vertebral bone surface, but in other embodiments, otherstructures or components may lie in between the bone facing surface 308and the bone surface of the vertebra. Each upper portion 304 and lowerportion 306 has one or more spaces or holes 312 oriented between thebone facing surface 308 and the access surface 310 that are configuredto accept helical or corkscrew shaped fixation devices for anchoring theimplant 300 to the vertebral bone. One or more spacers or spacingstructures 314 are located on the bone facing surface 308 of thefixation plate 302. The spacers 314 are typically integrated with thefixation plate 302 about the bone facing surface 308. The upper andlower surfaces 318, 320 are configured for facing the superior andinferior vertebral bodies adjacent to an implantation site. The relativeconfiguration of the upper surface 318 and lower surface 320 may vary,depending upon the relative position desired between the two adjacentvertebrae, the anatomical shape of the vertebrae, ease of insertion ofthe implant and other factors.

The holes 312 in the flange component may contain a groove 360,364configured to accept a helical fixation structure with correspondingpitch and diameter or with slightly larger diameter. The grooves 360 maybe configured to accept a helical fixation device with clockwiserotating helix or counterclockwise rotating helix 364. The hole may havea groove 340 at the interface with the proximal surface of the plate todirect initial placement of the helical fixation device, to engage witha corresponding feature in the helical fixation device to maintain itsfinal position, or both.

In FIG. 15, a plate 400 for spinal fixation is shown with holes 412configured to accept a helical fixation element. The grooves 460 may beconfigured to match a helical fixation structure in which the turns ofthe helix are configured in a clockwise fashion. Alternatively, some orall other grooves 464 may match a helical fixation structure configuredwith counter-clockwise turns. This may advantageously affect the pullout strength of the construct. Notches or grooves 440 in the plate mayinterfit with the proximal end of the helical structure as well asprovide the starting point for the tip of the helical fixation structuresuch that the tip will contact the bone at an appropriate angle.

In some embodiments, the patient can be intubated and general anesthesiacan be achieved. The patient can be prepped and draped in the usualsterile fashion. An anterior approach to the spine can be used to exposethe anterior vertebral bodies. Many anterior approaches to the vertebralcolumn are described in various medical texts such as Campbell'sOperative Orthopaedics, 10th ed., edited by Canale et al., pp.1569-1588, herein incorporated by reference. In some embodiments, theupper cervical spine can be accessed. The anterior upper cervical spinecan be accessed by a transoral or retropharyngeal route, or by using asubtotal or extended maxillotomy. In other embodiments, the lowercervical spine, cervicothoracic junction, thoracic spine, thoracolumbarjunction, lumbar region, lumbosacral junction, sacrum or combination ofthe above regions can be accessed.

The intervertebral space can be debrided. In some embodiments, a flangedinterbody implant can be packed with natural or artificial bone matrixand/or other osteogenesis factors and inserted into the intervertebralspace. The flange can be positioned against the anterior cervicalvertebral bodies and attached with one or more helically shaped wires.In other embodiments, an interbody spacer may be inserted into theintervertebral space and attached to a superior vertebral body, aninferior vertebral body, or both with one or more helically shapedstructures. Pilot hole in the vertebral body cortex may be prepared forthe one or more helically shaped structures using a punch. The helicallyshaped structures may be removably coupled to an inserter for theirinsertion. The inserter may comprise a handle, and may advance thehelically shaped structure by, for example, rotation or impaction of thehandle. The operative site can be irrigated with antibiotics and theoperative field can be sutured closed. The vertebral column can beaccessed and one or more intervertebral spaces can be identified andaccessed. In some embodiments, two or more intervertebral spaces can beaccessed, and in still other embodiments, two or more adjacentintervertebral spaces can be accessed. The operative site can be rinsedwith antibiotic solution and the operative field can be closed inlayers.

Although the present invention has been described in relation to variousexemplary embodiments, various additional embodiments and alterations tothe described embodiments are contemplated within the scope of theinvention. Thus, no part of the foregoing description should beinterpreted to limit the scope of the invention as set forth in thefollowing claims. For all of the embodiments described above, the stepsof the methods need not be performed sequentially.

1-20. (canceled)
 21. A method for treating a spine, comprising:inserting an interbody spacer between two vertebral bodies; engaging adistal tip of a helically-shaped wire with a notch at an interface witha hole of a plate, wherein the notch extends a helically shaped grooveto a proximal surface of the plate, the notch and the helically shapedgroove directly formed in the plate; and engaging the helically-shapedwire with the helically shaped groove and into a vertebral body adjacentto the interbody spacer, wherein the notch directs the initial placementof the distal tip of the helically-shaped wire into the vertebral body.22. The method of claim 21, further comprising maintaining a fullyinserted position of the helically-shaped wire in the vertebral body.23. The method of claim 21, further comprising limiting further rotationof the helically-shaped wire.
 24. The method of claim 21, furthercomprising limiting further insertion of the helically-shaped wire. 25.The method of claim 21, further comprising limiting further movement ofthe helically-shaped wire.
 26. A method for treating a spine,comprising: inserting at least a portion of an implant between twovertebral bodies; engaging a distal tip of a helically-shaped fixationdevice with a groove at an interface with a proximal surface of theimplant, wherein the groove provides a rotational starting point for thedistal tip; and engaging the distal tip of the helically-shaped fixationdevice with a helical groove directly formed in the implant, wherein thehelical groove provides a rotational ending point for the distal tipsuch that the distal tip contacts a vertebral body at a pre-determinedangle.
 27. The method of claim 26, further comprising maintaining afully inserted position of the helically-shaped fixation device in thevertebral body.
 28. The method of claim 26, further comprising limitingfurther rotation of the helically-shaped fixation device.
 29. The methodof claim 26, further comprising limiting further insertion of thehelically-shaped fixation device.
 30. The method of claim 26, furthercomprising limiting further movement of the helically-shaped fixationdevice.
 31. An interbody spacer system for the spine comprising: ahelically-shaped fixation device comprising a distal tip; an implanthaving a helical groove directly formed in the implant, wherein thehelical groove provides a rotational ending point for the distal tipsuch that the distal tip contacts a vertebral body at a pre-determinedangle, wherein the helical groove extends to an interface with aproximal surface of the implant; and a feature configured to limitfurther rotation of the helically-shaped fixation device relative to theimplant.
 32. The system of claim 31, wherein the feature comprises aportion of the helically-shaped fixation device and the implantconfigured to interlock.
 33. The system of claim 31, wherein the featurecomprises a portion of the helically-shaped fixation device configuredto limit rotation of the helically-shaped fixation device once thehelically-shaped fixation device reaches a fully inserted position. 34.The system of claim 31, wherein the feature comprises interlockingshapes of the helically-shaped fixation device and the implant.
 35. Thesystem of claim 31, wherein the feature comprises a protrusion of thehelically-shaped fixation device.
 36. The system of claim 31, whereinthe feature comprises a protrusion configured to interlock with agroove.
 37. The system of claim 31, wherein the feature comprises agroove at the proximal surface of the implant configured to interlockwith the helically-shaped fixation device.
 38. The system of claim 31,wherein the feature comprises a cap.
 39. The system of claim 31, whereinthe feature comprises a cap configured to be coupled to a proximal endof the helically-shaped fixation device.
 40. The system of claim 31,wherein the feature comprises a cap configured to engage a groove.